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临床试验/NCT07125651
NCT07125651尚未招募不适用

Prevalence of Gastrointestinal Bleeding in Ischemic Heart Disease Patients Undergoing Single Compared to Dual Antiplatelet Treatment

Assiut University0 个研究点目标入组 112 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
112
主要终点
Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatment

研究概览

简要总结

Gastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy. This study aims to compare the prevalence and risk of gastrointestinal bleeding in ischemic heart disease patients on single versus dual antiplatelet therapy, and to explore strategies for reducing gastrointestinal bleeding in these patients, enhancing treatment safety without compromising cardiovascular protection.

详细描述

Gastrointestinal (GI) bleeding refers to blood loss within the gastrointestinal tract, including the esophagus, stomach, small and large intestines, rectum, and anus. It is classified as upper GI bleeding-originating proximal to the ligament of Treitz (esophagus, stomach, first and second parts of the duodenum)-and lower GI bleeding, which originates distal to this ligament (remaining duodenum, jejunum, ileum, colon, rectum, and anus). GI bleeding may be acute, with sudden and severe blood loss, or chronic, involving slow, recurrent bleeding that is less obvious but still clinically significant.

Ischemic heart disease (IHD) is caused by reduced blood flow to the heart muscle due to narrowing or blockage of the coronary arteries, mainly from atherosclerosis. This can result in chest pain, heart attacks, and other cardiovascular complications.

Antiplatelet drugs, such as aspirin and clopidogrel, inhibit platelet aggregation to prevent blood clots and are essential in IHD management. Single antiplatelet therapy (SAPT) uses one agent, while dual antiplatelet therapy (DAPT) combines two agents for stronger protection against thrombotic events.

Both SAPT and DAPT improve cardiovascular outcomes in IHD patients, with SAPT commonly used for long-term prevention and DAPT recommended after acute coronary events or interventions.

Antiplatelet drugs, like aspirin and clopidogrel, increase GI bleeding risk by inhibiting platelet aggregation, impairing clot formation, and, in the case of aspirin, directly irritating the stomach lining, making it easier for ulcers or erosions to bleed. The risk is higher with dual therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (aged 18 years old and older) who were diagnosed ischemic heart disease on single or dual antiplatelet therapy and developed gastrointestinal bleeding (manifestation of hematemesis, melena or bleeding per rectum).

排除标准

  • Patients on anticoagulant.
  • Patients with bleeding tendencies.
  • Individuals with other comorbidities.
  • patients with acute coronary syndrome.
  • Uncooperative patients.

结局指标

主要结局

Prevalence of gastrointestinal bleeding in ischemic heart disease patients undergoing single compared to dual antiplatelet treatment

时间窗: Baseline

Gastrointestinal bleeding is blood loss in the digestive tract, classified as upper or lower. Ischemic heart disease is due to blocked heart arteries. Antiplatelet drugs help prevent heart attacks but increase GI bleeding risk, especially when used together as dual therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulrahman Antar Mohamed

Dr

Assiut University

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